Actively Recruiting
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
Led by International AIDS Vaccine Initiative · Updated on 2026-03-31
5500
Participants Needed
16
Research Sites
162 weeks
Total Duration
On this page
Sponsors
I
International AIDS Vaccine Initiative
Lead Sponsor
B
Biofabri, SLU
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase 2b, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of a candidate tuberculosis (TB) vaccine, MTBVAC, against TB disease in adolescents and adults aged 14-45 years, living in a TB endemic region.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 14 to 45 years on Study Day 1
- Completed informed consent process (or parental consent and assent if under 18) before any study procedures
- Able and willing to comply with study requirements, including follow-up visits
- General good health confirmed by medical history and physical exam
- Female participants who could become pregnant agree to use acceptable contraception from 21 days before vaccination to 2 months after
- Male participants agree to use barrier contraception with female partners for at least 2 weeks after vaccination
- No shared enclosed living space with someone diagnosed with TB during the 6 months prior to Study Day 1
- HIV negative at screening
- Negative clinical screening and sputum test for pulmonary TB at screening
You will not qualify if you...
- Acute illness or fever (temperature ≥37.5°C) on Study Day 1
- Suspicion or evidence of active TB disease at screening
- History of previous TB disease or TB treatment
- History of TB preventive therapy (except BCG vaccination)
- Received any investigational drug or vaccine within 42 days before Study Day 1 or planned use during the study
- Planned use of any licensed vaccine outside protocol from 28 days before to 28 days after vaccination
- Prior receipt of any investigational TB vaccine before Study Day 1 (except placebo with approval)
- Use of immunosuppressive medication within 42 days before Study Day 1 (except inhaled/topical corticosteroids)
- Confirmed or suspected immunosuppressive, immunodeficient, or autoimmune condition
- Participation in other investigational studies during the study period (except non-blood/tissue observational studies)
- Received immunoglobulin or blood products within 42 days before Study Day 1 or planned during study
- History of reactions or allergies to vaccine components
- Pregnant or lactating females or positive pregnancy test at screening
- Indeterminate IGRA test result at screening
- Any condition or history that may compromise safety or study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 16 locations
1
Victoria Biomedical Research Institute
Kisumu, Kenya
Actively Recruiting
2
Kenya Medical Research Institute
Nairobi, Kenya
Actively Recruiting
3
JOSHA Research
Bloemfontein, South Africa
Actively Recruiting
4
South African Tuberculosis Vaccine Initiative
Cape Town, South Africa
Actively Recruiting
5
TASK Applied Science Pty Ltd. TASK Delft
Cape Town, South Africa
Actively Recruiting
6
UCTLI CLII - Centre for Lung Infection and Immunity
Cape Town, South Africa
Actively Recruiting
7
University of Cape Town Lung Institute PtyLtd. Centre for Tuberculosis Research Innovation
Cape Town, South Africa
Actively Recruiting
8
Wellcome Centre for Infectious Diseases Research in Africa
Cape Town, South Africa
Actively Recruiting
9
Synergy Biomedical Research Institute
East London, South Africa
Actively Recruiting
10
TASK Eden Pty Ltd.
George, South Africa
Actively Recruiting
11
Perinatal HIV Research Unit
Johannesburg, South Africa
Actively Recruiting
12
Be Part Research Pty Ltd.
Paarl, South Africa
Actively Recruiting
13
The Aurum Institute Rustenburg Clinical Research Centre
Rustenburg, South Africa
Actively Recruiting
14
Desmond Tutu Health Foundation, Masiphumelele Research Office
Sunnydale, South Africa
Not Yet Recruiting
15
The Aurum Institute Tembisa Clinical Research Centre
Tembisa, South Africa
Actively Recruiting
16
Ifakara Health Institute
Dar es Salaam, Tanzania
Not Yet Recruiting
Research Team
E
Elana Van Brakel, MD
CONTACT
A
Ansuya Naidoo, MBChB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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